A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Florida Hospital Transplant Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Novartis
Information provided by:
Florida Hospital Transplant Center
ClinicalTrials.gov Identifier:
NCT00273559
First received: January 5, 2006
Last updated: May 8, 2008
Last verified: November 2007
  Purpose

The purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass, lipids, hypertension, and new onset diabetes.


Condition Intervention Phase
Kidney Diseases
Drug: prednisone
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation

Resource links provided by NLM:


Further study details as provided by Florida Hospital Transplant Center:

Primary Outcome Measures:
  • Acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient and graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of infection [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (health survey) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Incidence of post-transplant diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Incidence of osteopenia/osteoporosis at baseline and one year [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Renal function [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2006
Estimated Study Completion Date: December 2008
Groups/Cohorts Assigned Interventions
1
subjects who remain on steroids after discharge
2
Subjects will be off steroids at the time of discharge
Drug: prednisone
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.

Detailed Description:

The use of steroids after renal transplantation has been invaluable, resulting in higher rates of long term survival of the transplanted kidney. However, post-operative steroids are also associated with frequent post-operative and long term complications. There have been steroid elimination studies analyzing acute rejection rates, graft and patient survival. These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.

With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids. We hope to show a decreased rate of complications such as osteopenia/osteoporosis, new onset diabetes, and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension.

Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper. Those remaining on steroids will be discharged on prednisone 5 mg daily. Those in whom steroids are eliminated will be off prednisone by discharge.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

de novo renal transplant recipients

Criteria

Inclusion Criteria:

  • Patients undergoing a single renal transplant from deceased or living donor
  • Adults 18 years and older
  • First or second renal transplant
  • Capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
  • Women of child bearing age should have a negative serum pregnancy test

Exclusion Criteria:

  • Greater than 2 renal transplants
  • Age < 18 years
  • Patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
  • Cold ischemia time > 30 hours
  • History of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
  • HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) positive serology
  • Loss of previous transplant in < 1 year
  • History of non-compliance
  • Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
  • Multiple organ transplant
  • History of chronic steroid use except for inhaled steroids for asthma
  • Pregnant or lactating females
  • Women of childbearing potential not willing to use a reliable form of contraception.
  • Patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
  • Known sensitivity to study drugs or class of study drugs
  • Use of any investigational agent in the last 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273559

Locations
United States, Florida
Florida Hospital Transplant Center
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Florida Hospital Transplant Center
Genzyme, a Sanofi Company
Novartis
Investigators
Principal Investigator: Michael Angelis, MD Florida Hospital Transplant Center
  More Information

No publications provided

Responsible Party: Michael Angelis, MD, Florida Hospital Transplant Center
ClinicalTrials.gov Identifier: NCT00273559     History of Changes
Other Study ID Numbers: TL092005-1
Study First Received: January 5, 2006
Last Updated: May 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Hospital Transplant Center:
Renal Transplantation

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014